Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
- Conditions
- Cocaine Use Disorder
- Interventions
- Device: TMS to dmPFCDevice: TMS to dlPFCDevice: Sham iTBS
- Registration Number
- NCT05986578
- Brief Summary
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- non-treatment-seeking adults
- meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine Benzoylecgonine (BE) specimen (≥ 300 ng/mL) during intake
- be able to understand the consent form and provide written informed consent
- be able to provide the following verifiable information for a minimum of 2 contact persons: full legal name,email address, local mailing address, and as applicable, home, work, and cell phone numbers
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current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
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in the opinion of the principal investigator (PI), the presence of any medical, neurological, psychiatric, or physical condition, disease, or illness that, may: (a) compromise interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
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has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
- Structured Clinical Interview for DSM-5 (SCID-5)
- Columbia Suicide Severity Rating Scale (C-SSRS) Screener - Answers YES to Questions 3, 4, 5, or 6
- Assault & Homicidal Danger Assessment Tool - Key to Danger > 1
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medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
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history of brain surgery
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history of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
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moderate-to-severe heart disease
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history of stroke
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is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:
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clozapine137
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chlorpromazine137
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bupropion
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clomipramine hydrochloride
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amoxapine
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maprotiline hydrochloride
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diphenhydramine
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stimulants other than cocaine including the following:
- Dextroamphetamine and amphetamine
- Dextroamphetamine
- Lisdexamfetamine dimesylate
- Methamphetamine
- Methylphenidate
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tramadol
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isoniazid
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having conditions of probation or parole requiring reports of drug use to officers of the court
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personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
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serious head injury with loss of consciousness
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impending incarceration
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pregnant or nursing for female patients
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inability to read, write, or speak English
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for adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)
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hair style that is incompatible with EEG nets
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description dmPFC then dlPFC then sham iTBS TMS to dlPFC - shami iTBS then dmPFC then dl PFC TMS to dmPFC - shami iTBS then dmPFC then dl PFC Sham iTBS - dlPFC then dmPFC then Sham iTBS TMS to dmPFC - dlPFC then dmPFC then Sham iTBS TMS to dlPFC - dlPFC then dmPFC then Sham iTBS Sham iTBS - dmPFC then sham iTBS then dlPFC TMS to dlPFC - dmPFC then sham iTBS then dlPFC Sham iTBS - dlPFC then sham iTBS then dmPFC Sham iTBS - dmPFC then dlPFC then sham iTBS TMS to dmPFC - dmPFC then dlPFC then sham iTBS Sham iTBS - dmPFC then sham iTBS then dlPFC TMS to dmPFC - dlPFC then sham iTBS then dmPFC TMS to dmPFC - sham iTBS then dlPFC then dmPFC TMS to dlPFC - dlPFC then sham iTBS then dmPFC TMS to dlPFC - sham iTBS then dlPFC then dmPFC TMS to dmPFC - sham iTBS then dlPFC then dmPFC Sham iTBS - shami iTBS then dmPFC then dl PFC TMS to dlPFC -
- Primary Outcome Measures
Name Time Method Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task. Baseline(before iTBS session),immediately after iTBS session The Picture Viewing Task will be used to elicit the LPP, reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slide show of images including pleasant, unpleasant, neutral, and cocaine-related images.
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task Baseline(before iTBS session),immediately after iTBS session The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.
- Secondary Outcome Measures
Name Time Method Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS) Baseline(before iTBS session),immediately after iTBS session The intensity of craving score will be used, scored from 1(none at all) to 10 (a great deal).
Change in pain as assessed by the Visual Analogue Scale Baseline(before iTBS session),immediately after iTBS session This is scored from 1(no pain) to 10 (worst pain)
Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA) Baseline(before iTBS session),immediately after iTBS session Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task Baseline(before iTBS session),immediately after iTBS session In the first "learning" phase, participants learn whether to press a button or withhold a response to receive a monetary reward or avoid a loss. In the second "transfer" phase, participants perform a forced choice task, where each of the predictive cues in the learning phase are paired with each other. Participants must select the "most rewarding" cue.
Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS) Baseline(before iTBS session),immediately after iTBS session This is a 14 item questionnaire. 9 of the questions are scored from 0(strongly disagree) to 3( strongly agree) and the rest are reverse coded with answer choices as follows: definitely agree, agree, disagree, and strongly disagree. Final scores range from 0-14 and higher score indicates worse outcome.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States